Process Development Engineer II

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

A Brief Overview

The Engineering team is responsible for the innovation of new production systems as well as the industrialization and sustainment of such systems. This role will be part of the team that owns development of new processes and leads a robust technical transfer to the industrialization team. The ideal candidate will have proven skills in the areas of project management, automated medical process development, mass production, medical equipment validation, medical process validation, or experience of the above in another highly regulated field. The Process development engineer is responsible to develop automated processes that support the mass production of new and/or existing products. This role will create automated systems for mass production that integrate processes such as cutting/heat sealing, lamination, pick-n-place systems, assembly, ultrasonic welding, precision filling, capping, label placement and packaging. Need proven skills in the areas of automated medical process development, mass production, design for manufacturability, and medical equipment/process validation practices. Must be able to collaborate with automation vendors, suppliers, and internal cross functional teams to ensure effective development, validation, and lean management of production cells. Support company goals, policies, and procedures while complying with applicable regulations. Responsible for assisting or leading the development and performance of validations on equipment. Supports applicable regulations including ISO13485, Local, State, and/or Federal requirements.

What you will do

· Design, implement, and successfully scale-up automated and semi-automated solutions based upon sound engineering principles

· Lead initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits.

· Collaborate closely with onsite and global partners to define, develop and deploy automated processing technologies including equipment, and processes for single-use disposables.

· Develop user requirements based on product, process, and quality needs for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate specific requirements into functional and design specifications

· Lead hands-on activities that support process development and process characterization, including drafting procedures, execution of prototype studies,

authoring technical reports, and participating on multi-functional risk assessment teams

· Support management in business case analysis for new projects which includes inputs such as current and forecasted capacity, standard cost analysis, and ROI.

· Develop automated manufacturing processes by sourcing relevant technology and/or collaborating with automation vendors to design customized medical device manufacturing equipment to improve safety, quality, efficiency and cost within the manufacturing environment

· Keep abreast of meaningful technical trends and developments and incorporates them into appropriate assignments

· Lead the project management of automation development by using visual project management tools (MS Project, critical path analysis, etc.). Define, manage, and communicate project timelines and risks

· Perform Design for Manufacturing DFM, Design of Experiments DOE and design/process Failure Mode and Effects Analysis (DFMEA/PFMEA)

· Collaborate with the Industrialization team for the development of validation protocols as well as its execution and reporting (for installation qualifications, operational qualifications, performance qualifications and process validations).

· Travel to the vendor sites as needed for equipment development, FAT, or to drive project timeliness.

· Collaborate with the Industrialization team and Maintenance Engineering to troubleshoot manufacturing processes/equipment to resolve production or equipment issues.

· Use CAD to design/review/update tooling and fixtures (SolidWorks Preferred)

· Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.

· Support the company’s continuous improvement efforts by supporting assignments in other areas as required.

· Perform other related duties as required or assigned.

Education Qualifications

· Engineering degree or related experience (+5 years) required

Experience Qualifications

· Medical products GMP manufacturing experience or another highly regulated field required

· Successful experience of working in multi-functional teams required

· Experience with development programs required

· Experience in a variety of robotic assembly applications required

· Robot and PLC simulation experience required

· Experience with field bus networks, serial communication and Ethernet communication required

· Experience in fast-paced iterative design and manufacturing environments required

· Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team required

Training and Skills

· Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing, clean room environments

· Exposure to a wide variety of production machinery, industrial sensors, and equipment.

· Excellent communication skills both written and verbal

· Ability to think critically, and demonstrated troubleshooting and problem-solving skills

· Excellent interpersonal, verbal and written communication skills

· Ability to function efficiently and independently in a fast-changing environment

· Self-motivated and willing to accept temporary responsibilities outside of initial job description

· Design, simulate (prototyping), and implement a fully automated controls architecture to build high volume products

· Utilize mechanical automation equipment, robots, PLCs, motion controls, and 3D vision to create entire assembly lines

· Influence the product design in order to simplify and optimize the factory process

· Implement reliable safety systems (ANSI / RIA15.06, OSHA) for safeguarding robots, gantries, conveyors and other high volume manufacturing equipment

· Ability to read, analyze, and interpret equipment manuals, electrical/mechanical/P&I schematics, general business periodicals, professional journals, technical procedures, and/or governmental regulations.

· Ability to write reports, business correspondence, manufacturing documents, maintenance schedules, and standard operating procedures.

· Ability to effectively present technical information and respond to questions from a variety of people that include managers, clients, customers, vendors, and the general public.

· Ability to handle and reason through complex information, define problems, collect data, establish facts, and draw objective conclusions.

· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

· Able to leverage project management & technical experience to foresight potential problems and develop contingency plans to ensure swift recovery in case of adversity. When facing unforeseen challenges must be able to deconstruct a problem effectively in order to find the best and fastest solution.

· Must be able to reason and communicate clearly under pressure. Fast learner and adaptable to medical device processes and regulations

Licenses and Certifications

· Certification in Lean/Six-sigma preferred

Standard Physical Demands

· Specific vision requirements involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. - Constantly

· Extended work hours to lead equipment troubleshooting/repairs when needed. This may include weekends or after-hours on-call support to ensure equipment is operational to support production plans - Occasionally

Standard Working Conditions

· Exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals - Occasionally

· The noise level in the work environment is usually moderate and sometimes loud. - Occasionally

Travel Requirements

· 20%

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. 

What we offer

Receive a competitive salary $75,000-$120,000 annual salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.